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Cingulate gets FDA complete response letter for ADHD drug CTx-1301 on CMC issues

PUBT·06/02/2026 12:03:10
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Cingulate gets FDA complete response letter for ADHD drug CTx-1301 on CMC issues
  • Cingulate received an FDA Complete Response Letter for its NDA for CTx-1301 to treat ADHD.
  • FDA requests focus on Chemistry, Manufacturing and Controls information; no current clinical safety or efficacy issues were cited.
  • Cingulate plans a prompt resubmission once the CMC work with its manufacturing partner is completed.
  • Nearly $30 million in cash on hand was cited as sufficient to support the response and pre-commercial activities into 2027.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cingulate Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606020800PRIMZONEFULLFEED9730238) on June 02, 2026, and is solely responsible for the information contained therein.